Prevents postmenopausal osteoporosis ( 1.1, 1.2 ). Sold as Zometa, Reclast, Zoledronic Acid. Every FDA application for this active ingredient: 6 branded and 48 generic.
As of Nov 14, 2026, FDA lists 54 applications for Zoledronic Acid (sold as Zometa, Reclast, Zoledronic Acid), first approved Aug 20, 2001, with 6 new uses approved and 0 published complete response letters.
| Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMDOsteoporosis in Post-menopausal Women · Sahlgrenska University Hospital | Phase 4 | Not yet recruiting | Aug 19, 2026 |
| Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to MINST of Intrabony Defects in Controlled Type 2 DMControlled Type 2 Diabetic Patients With Periodontitis · Cairo University | Not applicable | Not yet recruiting | Aug 7, 2026 |
| Pharmacokinetics of Zoledronic Acid in Patients on DialysisChronic Kidney Disease, Osteoporosis · University of Campinas, Brazil | Phase 1 | Not yet recruiting | Aug 3, 2026 |
| Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone MetastasesBreast Cancer, Stage IV Breast Cancer · West China Hospital | Not applicable | Not yet recruiting | Jul 7, 2026 |
| EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITISOsteomyelitis Chronic · Assistance Publique - Hôpitaux de Paris | Phase 2 | Not yet recruiting | Jun 25, 2026 |
| Zoledronic Acid Treatment in Patients With Congenital Dyserythropoietic AnemiaCongenital Dyserythropoietic Anemia (CDA) · Institute of Hematology & Blood Diseases Hospital, China | Phase 1 / Phase 2 | Recruiting | Mar 13, 2026 |
| The Comparison of Ibandronate and Zoledronic Acid After Denosumab DiscontinuationPostmenopausal Osteoporosis, Postmenopausal Osteopenia · National Taiwan University Hospital | Phase 4 | Recruiting | Feb 12, 2026 |
| Zoledronate to Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant SurvivorsHematopoietic Stem Cell Transplantation · Children's Hospital Medical Center, Cincinnati | Phase 1 | Recruiting | Jan 29, 2026 |
| Aug 20, 2001 | ZometaNDA 21223 · New molecular entity | Novartis | 28 | Discontinued |
| Feb 22, 2002 | ZometaNDA 21386 · TYPE 6 | Novartis | 2 | Marketed |
| Apr 16, 2007 | ReclastNDA 21817 · New dosage form | Sandoz | 20 | Marketed |
| Aug 17, 2007 | ReclastNDA 22080 · TYPE 6 | Sandoz | 0 | Marketed |
| Mar 4, 2013 | Zoledronic AcidANDA 90018 | Sun Pharma Global | 0 | Discontinued |
| Mar 4, 2013 | Zoledronic AcidANDA 202472 | Actavis Inc | 5 | Discontinued |
| Mar 4, 2013 | Zoledronic AcidANDA 202746 | Sun Pharma Global | 1 | Discontinued |
| Mar 4, 2013 | Zoledronic AcidANDA 91170 | Breckenridge | 6 | Discontinued |
| Mar 4, 2013 | Zoledronic AcidANDA 91186 | Dr Reddys Labs Ltd | 7 | Marketed |
| Mar 4, 2013 | Zoledronic AcidANDA 202650 | Mylan Labs Ltd | 5 | Marketed |
| Mar 12, 2013 | Zoledronic AcidANDA 201783 | Avet Lifesciences | 6 | Marketed |
| Mar 29, 2013 | Zoledronic AcidANDA 91363 | Dr Reddys Labs Ltd | 4 | Marketed |
| Mar 29, 2013 | Zoledronic AcidANDA 201801 | Avet Lifesciences | 2 | Discontinued |
| Apr 5, 2013 | Zoledronic AcidANDA 202837 | Hospira Inc | 5 | Discontinued |
| May 7, 2013 | Zoledronic AcidANDA 202571 | Chartwell Rx | 0 | Marketed |
| Jun 3, 2013 | Zoledronic AcidANDA 202182 | Hikma Farmaceutica | 4 | Marketed |
| Aug 2, 2013 | Zoledronic AcidNDA 203231 · New formulation or manufacturer | Inforlife | 15 | Marketed |
| Aug 5, 2013 | Zoledronic AcidANDA 202163 | Chartwell Rx | 3 | Marketed |
| Aug 5, 2013 | Zoledronic AcidANDA 202930 | Gland | 7 | Marketed |
| Sep 23, 2013 | Zoledronic AcidANDA 202828 | Inforlife | 8 | Marketed |
| May 22, 2014 | Zoledronic AcidANDA 202548 | Epic Pharma LLC | 4 | Marketed |
| Aug 21, 2014 | Zoledronic AcidANDA 200918 | Epic Pharma LLC | 1 | Marketed |
| Sep 4, 2014 | Zoledronic AcidANDA 202923 | Usv | 5 | Marketed |
| Nov 24, 2014 | Zoledronic AcidANDA 91493 | Sagent Pharms Inc | 6 | Marketed |
| Mar 19, 2015 | Zoledronic AcidANDA 90621 | Hospira | 2 | Discontinued |
| Apr 23, 2015 | Zoledronic AcidANDA 91516 | Fresenius Kabi USA | 0 | Marketed |
| Dec 24, 2015 | Zoledronic AcidANDA 204367 | Apotex | 3 | Discontinued |
| Dec 28, 2015 | Zoledronic AcidNDA 204016 · New formulation or manufacturer | Hospira | 2 | Discontinued |
| Aug 18, 2016 | Zoledronic AcidANDA 204217 | Gland | 2 | Marketed |
| Sep 26, 2016 | Zoledronic AcidANDA 207751 | Eugia Pharma | 2 | Discontinued |
| Nov 28, 2016 | Zoledronic AcidANDA 205279 | Accord Hlthcare | 3 | Marketed |
| Feb 14, 2017 | Zoledronic AcidANDA 203841 | Mylan Labs Ltd | 2 | Marketed |
| Oct 27, 2017 | Zoledronic AcidANDA 205254 | Mylan Labs Ltd | 2 | Marketed |
| Oct 27, 2017 | Zoledronic AcidANDA 210174 | Amneal | 1 | Marketed |
| Dec 8, 2017 | Zoledronic AcidANDA 209125 | Eugia Pharma | 3 | Discontinued |
| Dec 29, 2017 | Zoledronic AcidANDA 207341 | Bpi Labs | 0 | Marketed |
| Jun 29, 2018 | Zoledronic, Zoledronic AcidANDA 205749 | Gland | 1 | Marketed |
| Nov 19, 2018 | Zoledronic AcidANDA 204344 | Dr Reddys | 0 | Discontinued |
| May 15, 2019 | Zoledronic AcidANDA 208513 | Adaptis | 0 | Discontinued |
| Aug 8, 2019 | Zoledronic AcidANDA 209578 | Gland | 1 | Marketed |
| Feb 19, 2020 | Zoledronic AcidANDA 208968 | Ingenus Pharms LLC | 0 | Discontinued |
| Jun 5, 2023 | Zoledronic AcidANDA 213371 | Meitheal | 0 | Marketed |
| Feb 5, 2026 | Zoledronic AcidANDA 219984 | Gland | 0 | Marketed |
| — | Zoledronic AcidANDA 78533 | Apotex Inc | 0 | Discontinued |
| — | Zoledronic AcidANDA 78475 | Cipla Ltd | 0 | Discontinued |
| — | Zoledronic AcidANDA 78576 | Teva Parenteral | 0 | Discontinued |
| — | Zoledronic AcidANDA 78580 | Teva Parenteral | 0 | Discontinued |
| — | Zoledronic AcidANDA 90330 | Pharmaforce | 0 | Discontinued |
| — | Zoledronic AcidANDA 90709 | Hospira Inc | 0 | Discontinued |
| — | Zoledronic AcidANDA 91187 | Dr Reddys Labs Ltd | 0 | Discontinued |
| — | Zoledronic AcidANDA 91364 | Dr Reddys Labs Ltd | 0 | Discontinued |
| — | Zoledronic AcidANDA 203344 | Pfizer Inc | 0 | Discontinued |
| — | Zoledronic AcidANDA 204051 | Sun Pharma Global | 0 | Discontinued |
| — | Zoledronic AcidANDA 204138 | Sun Pharma Global | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Novartis
Sandoz
Mylan Labs Ltd
Fresenius Kabi USA
Apotex
Eugia Pharma
Accord Hlthcare